Heart Failure, SystolicNCT06121323
Physiological Effects of Lactate in Individuals With Chronic Heart Failure
A study testing Sodium lactate infusion and Sodium lactate ingestion in people with Heart Failure, Systolic, run by Henrik Wiggers at 1 site in Denmark.
Trial summary
Background: Lactate is continuously produced in the human body through two primary processes: glycolysis and microbial fermentation in the gastrointestinal tract. At rest, its concentration in the bloodstream typically ranges from 1 to 2 mmol/L. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Sodium lactate infusion and Sodium lactate ingestion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2023to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure
- NYHA II-III
- Left ventricular ejection fraction <40%
- Negative urine-HCG for women with childbearing potential
Who cannot join
- Diabetes or HbA1c >48 mmol/mol
- Significant cardiac valve disease
- Severe stable angina pectoris
- Severe comorbidity as judged by the investigator
- Inability to give informed consent
- Age <18 years
- Other disease or treatment making subject unsuitable for study participation as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Lactate is continuously produced in the human body through two primary processes: glycolysis and microbial fermentation in the gastrointestinal tract. At rest, its concentration in the bloodstream typically ranges from 1 to 2 mmol/L. However, during periods of physical exertion or insufficient oxygen supply, such as during intense exercise, lactate levels significantly increase. Traditionally, lactate was perceived as a byproduct of anaerobic metabolism. Nevertheless, emerging research has illuminated its vital role as both a signaling molecule and a crucial energy source for vital organs like skeletal muscle, brain, and the heart.
Read more
Objectives:
The primary aim of this study is to investigate the impact of physiological levels of circulating lactate on the hemodynamics of individuals with chronic heart failure. This research seeks to understand how lactate affects the cardiovascular response in this specific patient population.
Design and Endpoints:
The study design employs a double-blind, randomized crossover approach involving 12 heart failure patients. Each participant will undergo two separate visits.
Visit 1: Participants will receive a three-hour intravenous infusion of either a racemic (D/L) mixture of sodium lactate or an intravenous isotonic sodium chloride placebo, with a subsequent crossover to the opposite infusion on the same day.
Visit 2: Similar to the first visit, participants will receive either an orally administered racemic (D/L) mixture of sodium lactate or an isocaloric, isovolumic oral placebo (maltodextrin), with a crossover to the opposite administration after three hours.
The study's endpoints include cardiac output (primary), mixed venous saturation (SVO2), pulmonary wedge pressure, resting echocardiography (left ventricular ejection fraction and myocardial work efficiency), and measurements of vasoactive substances in blood samples.
Methods:
The study employs invasive Swan-Ganz monitoring to measure cardiac output, echocardiography, and frequent venous blood sample collections. These measurements and samples will be taken at specific intervals during the study visits.
Intervention:
To investigate the isolated hemodynamic and physiological effects of lactate, the study utilizes lactate infusion and ingestion to induce a state of hyperlactatemia within the physiological range. The intended dosages aim to stay within the physiological range, with no values expected to exceed 3-4 mmol/L.
- Conditions
- Heart Failure, Systolic
- Being tested
- Sodium lactate infusion, Sodium lactate ingestion
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium lactate infusionOther
Dosage of sodium-lactate: 0.5 mol/L; 3 mL/kg/time; maximal 300 mL/hour.
Sodium lactate ingestionOther
Oral dose is equal to the i.v. dose.
| Study group | Role | What they receive |
|---|---|---|
| Lactate infusion | Active comparator | All participants will be randomized to first receive a three-hour intravenous infusion with either a racemic (D/L) mixture of sodium lactate or intravenous isotonic sodium chloride placebo. All participants will then cross over to the converse infusion on the same day. Receives: Other: Sodium lactate infusion |
| Lactate ingestion | Active comparator | All participants will be randomized to first receive either an orally administered racemic (D/L) mixture of sodium lactate or isocaloric, isovolumic oral placebo (maltodextrin). The oral dose of lactate will be equal to the intravenous dose. All participants will be studied for three hours and then cross over to receive the converse oral administration following additional three hours of observation time on the same day. Receives: Other: Sodium lactate ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output Cardiac output
Unit: L/min.
It represents the amount of blood that the heart pumps out of the left ventricle per minute.
Measured: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Secondary outcomes (4)
Mixed venous saturation (SVO2)
Unit: %
It represents the percentage of oxygen saturation in the blood as it returns to the right side of the heart after circulating through the body's tissues.
Measured: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Pulmonary wedge pressure
Unit: mmHg
It reflects the pressure within the left atrium and the left ventricle of the heart, and it is an important indicator of left ventricular preload.
Measured: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Left ventricular ejection fraction
Unit: %
It is a measure of the percentage of blood that is pumped out of the left ventricle with each heartbeat.
Measured: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Global longitudinal strain
Unit: %
It quantifies the deformation or shortening of the heart muscle fibers along the longitudinal (lengthwise) axis of the left ventricle during the cardiac cycle.
Measured: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start22 Nov 2023
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Wiggers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Wiggers, Aarhus University Hospital
- Investigators
- Henrik Wiggers, Professor, Study chair, Dept. of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121323
- Sponsor's protocol ID
- LACTATE-CHF
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodwin ML, Harris JE, Hernandez A, Gladden LB. Blood lactate measurements and analysis during exercise: a guide for clinicians. J Diabetes Sci Technol. 2007 Jul;1(4):558-69. doi: 10.1177/193229680700100414.
PubMed 19885119Vincent JL, Quintairos E Silva A, Couto L Jr, Taccone FS. The value of blood lactate kinetics in critically ill patients: a systematic review. Crit Care. 2016 Aug 13;20(1):257. doi: 10.1186/s13054-016-1403-5.
PubMed 27520452Brooks GA. The tortuous path of lactate shuttle discovery: From cinders and boards to the lab and ICU. J Sport Health Sci. 2020 Sep;9(5):446-460. doi: 10.1016/j.jshs.2020.02.006. Epub 2020 Feb 21.
PubMed 32444344Johannsson E, Lunde PK, Heddle C, Sjaastad I, Thomas MJ, Bergersen L, Halestrap AP, Blackstad TW, Ottersen OP, Sejersted OM. Upregulation of the cardiac monocarboxylate transporter MCT1 in a rat model of congestive heart failure. Circulation. 2001 Aug 7;104(6):729-34. doi: 10.1161/hc3201.092286.
PubMed 11489783Liu C, Wu J, Zhu J, Kuei C, Yu J, Shelton J, Sutton SW, Li X, Yun SJ, Mirzadegan T, Mazur C, Kamme F, Lovenberg TW. Lactate inhibits lipolysis in fat cells through activation of an orphan G-protein-coupled receptor, GPR81. J Biol Chem. 2009 Jan 30;284(5):2811-2822. doi: 10.1074/jbc.M806409200. Epub 2008 Dec 1.
PubMed 19047060Offermanns S. Hydroxy-Carboxylic Acid Receptor Actions in Metabolism. Trends Endocrinol Metab. 2017 Mar;28(3):227-236. doi: 10.1016/j.tem.2016.11.007. Epub 2017 Jan 10.
PubMed 28087125Engelstoft MS, Park WM, Sakata I, Kristensen LV, Husted AS, Osborne-Lawrence S, Piper PK, Walker AK, Pedersen MH, Nohr MK, Pan J, Sinz CJ, Carrington PE, Akiyama TE, Jones RM, Tang C, Ahmed K, Offermanns S, Egerod KL, Zigman JM, Schwartz TW. Seven transmembrane G protein-coupled receptor repertoire of gastric ghrelin cells. Mol Metab. 2013 Sep 4;2(4):376-92. doi: 10.1016/j.molmet.2013.08.006. eCollection 2013.
PubMed 24327954Pedersen MGB, Sondergaard E, Nielsen CB, Johannsen M, Gormsen LC, Moller N, Jessen N, Rittig N. Oral lactate slows gastric emptying and suppresses appetite in young males. Clin Nutr. 2022 Feb;41(2):517-525. doi: 10.1016/j.clnu.2021.12.032. Epub 2021 Dec 24.
PubMed 35016146Nalos M, Leverve X, Huang S, Weisbrodt L, Parkin R, Seppelt I, Ting I, Mclean A. Half-molar sodium lactate infusion improves cardiac performance in acute heart failure: a pilot randomised controlled clinical trial. Crit Care. 2014 Mar 25;18(2):R48. doi: 10.1186/cc13793.
PubMed 24666826Leverve XM, Boon C, Hakim T, Anwar M, Siregar E, Mustafa I. Half-molar sodium-lactate solution has a beneficial effect in patients after coronary artery bypass grafting. Intensive Care Med. 2008 Oct;34(10):1796-803. doi: 10.1007/s00134-008-1165-x. Epub 2008 Jun 18.
PubMed 18563389Murashige D, Jang C, Neinast M, Edwards JJ, Cowan A, Hyman MC, Rabinowitz JD, Frankel DS, Arany Z. Comprehensive quantification of fuel use by the failing and nonfailing human heart. Science. 2020 Oct 16;370(6514):364-368. doi: 10.1126/science.abc8861.
PubMed 33060364Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.
PubMed 30884964
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Lactate in Individuals With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06121323
- Acronym / sponsor ID
- LACTATE-CHF
- Conditions
- Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henrik WiggersUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Lactate is continuously produced in the human body through two primary processes: glycolysis and microbial fermentation in the gastrointestinal tract. At rest, its concentration in the bloodstream typically ranges from 1 to 2 mmol/L. However, during periods of physical exertion or insufficient oxygen supply, such as during intense exercise, lactate levels significantly increase. Traditionally, lactate was perceived as a byproduct of anaerobic metabolism. Nevertheless, emerging research has illuminated its vital role as both a signaling molecule and a crucial energy source for vital organs like skeletal muscle, brain, and the heart.
Objectives:
The primary aim of this study is to investigate the impact of physiological levels of circulating lactate on the hemodynamics of individuals with chronic heart failure. This research seeks to understand how lactate affects the cardiovascular response in this specific patient population.
Design and Endpoints:
The study design employs a double-blind, randomized crossover approach involving 12 heart failure patients. Each participant will undergo two separate visits.
Visit 1: Participants will receive a three-hour intravenous infusion of either a racemic (D/L) mixture of sodium lactate or an intravenous isotonic sodium chloride placebo, with a subsequent crossover to the opposite infusion on the same day.
Visit 2: Similar to the first visit, participants will receive either an orally administered racemic (D/L) mixture of sodium lactate or an isocaloric, isovolumic oral placebo (maltodextrin), with a crossover to the opposite administration after three hours.
The study's endpoints include cardiac output (primary), mixed venous saturation (SVO2), pulmonary wedge pressure, resting echocardiography (left ventricular ejection fraction and myocardial work efficiency), and measurements of vasoactive substances in blood samples.
Methods:
The study employs invasive Swan-Ganz monitoring to measure cardiac output, echocardiography, and frequent venous blood sample collections. These measurements and samples will be taken at specific intervals during the study visits.
Intervention:
To investigate the isolated hemodynamic and physiological effects of lactate, the study utilizes lactate infusion and ingestion to induce a state of hyperlactatemia within the physiological range. The intended dosages aim to stay within the physiological range, with no values expected to exceed 3-4 mmol/L.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactate infusion | Active comparator | Other: Sodium lactate infusionAll participants will be randomized to first receive a three-hour intravenous infusion with either a racemic (D/L) mixture of sodium lactate or intravenous isotonic sodium chloride placebo. All participants will then cross over to the converse infusion on the same day. |
| Lactate ingestion | Active comparator | Other: Sodium lactate ingestionAll participants will be randomized to first receive either an orally administered racemic (D/L) mixture of sodium lactate or isocaloric, isovolumic oral placebo (maltodextrin). The oral dose of lactate will be equal to the intravenous dose. All participants will be studied for three hours and then cross over to receive the converse oral administration following additional three hours of observation time on the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic heart failure
- NYHA II-III
- Left ventricular ejection fraction <40%
- Negative urine-HCG for women with childbearing potential
Key exclusion criteria (7 listed)
- Diabetes or HbA1c >48 mmol/mol
- Significant cardiac valve disease
- Severe stable angina pectoris
- Severe comorbidity as judged by the investigator
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium lactate infusionDosage of sodium-lactate: 0.5 mol/L; 3 mL/kg/time; maximal 300 mL/hour. | Other | Lactate infusion |
| Sodium lactate ingestionOral dose is equal to the i.v. dose. | Other | Lactate ingestion |
Primary outcome
Cardiac output Cardiac output
Time frame: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Unit: L/min. It represents the amount of blood that the heart pumps out of the left ventricle per minute.
4 secondary outcomes
Mixed venous saturation (SVO2)
Time frame: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Pulmonary wedge pressure
Time frame: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Left ventricular ejection fraction
Time frame: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Global longitudinal strain
Time frame: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 19885119Goodwin ML, Harris JE, Hernandez A, Gladden LB. Blood lactate measurements and analysis during exercise: a guide for clinicians. J Diabetes Sci Technol. 2007 Jul;1(4):558-69. doi: 10.1177/193229680700100414.
- Background: PubMed 27520452Vincent JL, Quintairos E Silva A, Couto L Jr, Taccone FS. The value of blood lactate kinetics in critically ill patients: a systematic review. Crit Care. 2016 Aug 13;20(1):257. doi: 10.1186/s13054-016-1403-5.
- Background: PubMed 32444344Brooks GA. The tortuous path of lactate shuttle discovery: From cinders and boards to the lab and ICU. J Sport Health Sci. 2020 Sep;9(5):446-460. doi: 10.1016/j.jshs.2020.02.006. Epub 2020 Feb 21.
- Background: PubMed 11489783Johannsson E, Lunde PK, Heddle C, Sjaastad I, Thomas MJ, Bergersen L, Halestrap AP, Blackstad TW, Ottersen OP, Sejersted OM. Upregulation of the cardiac monocarboxylate transporter MCT1 in a rat model of congestive heart failure. Circulation. 2001 Aug 7;104(6):729-34. doi: 10.1161/hc3201.092286.
- Background: PubMed 19047060Liu C, Wu J, Zhu J, Kuei C, Yu J, Shelton J, Sutton SW, Li X, Yun SJ, Mirzadegan T, Mazur C, Kamme F, Lovenberg TW. Lactate inhibits lipolysis in fat cells through activation of an orphan G-protein-coupled receptor, GPR81. J Biol Chem. 2009 Jan 30;284(5):2811-2822. doi: 10.1074/jbc.M806409200. Epub 2008 Dec 1.
- Background: PubMed 28087125Offermanns S. Hydroxy-Carboxylic Acid Receptor Actions in Metabolism. Trends Endocrinol Metab. 2017 Mar;28(3):227-236. doi: 10.1016/j.tem.2016.11.007. Epub 2017 Jan 10.
- Background: PubMed 24327954Engelstoft MS, Park WM, Sakata I, Kristensen LV, Husted AS, Osborne-Lawrence S, Piper PK, Walker AK, Pedersen MH, Nohr MK, Pan J, Sinz CJ, Carrington PE, Akiyama TE, Jones RM, Tang C, Ahmed K, Offermanns S, Egerod KL, Zigman JM, Schwartz TW. Seven transmembrane G protein-coupled receptor repertoire of gastric ghrelin cells. Mol Metab. 2013 Sep 4;2(4):376-92. doi: 10.1016/j.molmet.2013.08.006. eCollection 2013.
- Background: PubMed 35016146Pedersen MGB, Sondergaard E, Nielsen CB, Johannsen M, Gormsen LC, Moller N, Jessen N, Rittig N. Oral lactate slows gastric emptying and suppresses appetite in young males. Clin Nutr. 2022 Feb;41(2):517-525. doi: 10.1016/j.clnu.2021.12.032. Epub 2021 Dec 24.
- Background: PubMed 24666826Nalos M, Leverve X, Huang S, Weisbrodt L, Parkin R, Seppelt I, Ting I, Mclean A. Half-molar sodium lactate infusion improves cardiac performance in acute heart failure: a pilot randomised controlled clinical trial. Crit Care. 2014 Mar 25;18(2):R48. doi: 10.1186/cc13793.
- Background: PubMed 18563389Leverve XM, Boon C, Hakim T, Anwar M, Siregar E, Mustafa I. Half-molar sodium-lactate solution has a beneficial effect in patients after coronary artery bypass grafting. Intensive Care Med. 2008 Oct;34(10):1796-803. doi: 10.1007/s00134-008-1165-x. Epub 2008 Jun 18.
- Background: PubMed 33060364Murashige D, Jang C, Neinast M, Edwards JJ, Cowan A, Hyman MC, Rabinowitz JD, Frankel DS, Arany Z. Comprehensive quantification of fuel use by the failing and nonfailing human heart. Science. 2020 Oct 16;370(6514):364-368. doi: 10.1126/science.abc8861.
- Background: PubMed 30884964Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Wiggers, Professor study chair
Dept. of Cardiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium lactate infusion and Sodium lactate ingestion in people with Heart Failure, Systolic, run by Henrik Wiggers at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output Cardiac output (time frame: Two visits of six hours each separated by a one-week washout period. Thus, outcome measures for the intravenous route will be assessed at week one, and outcome measures for the oral route will be assessed at week 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121323, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.